Gabapentin

Product NDC
50090-5961
Requested package NDC
50090-5961-0
11-digit product format
500905961
Labeler code
50090
Product ID
50090-5961_63ffaba7-e141-43a3-ad3f-e73e549663aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090858
Marketing category
ANDA
Marketing start
2021-07-15
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-596150090-5961-0IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090858-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2010-12-17
A090858-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2010-12-17
A090858-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2010-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090858-001AB
A090858-002AB
A090858-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090858-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090858-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5961-0Gabapentin33 in 1 CARTONCAPSULE331
50090-5961-0Gabapentin1 in 1 BLISTER PACKCAPSULE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5961-0EA - Each50090-59610a0b9e43-d2df-459b-9fba-82e82237046c12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5961GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20220416_7eddc9ac-03ba-44c0-b630-ab683bf31e8e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAscend Laboratories, LLC722de2a9-38b3-4518-b262-ba0d1346d0ba2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINBryant Ranch Prepacka1006139-7dfc-4d87-a5a9-aeb380c32d242026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.896c7782-1137-454b-aaa6-28f42c7413ef2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINBryant Ranch Prepack6a0a75ac-e121-477b-a9d1-d11f588afc9d2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.7652adc6-1aad-4422-b85c-0c6b11c23b732026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.d06380d0-c894-427e-b13e-5a8f9eb86a342026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.78445dbf-c7cd-419f-a7be-72821e4966282026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINMajor Pharmaceuticals36f74fdf-0dae-47a0-a7ea-e64ac91cd88f2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINHAWAII REPACK, INC.14d61caa-17ce-4fa2-90fb-1470f3864be82026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINNorthwind Health Company, LLC552912b2-be59-0333-e063-6394a90a85c02026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINNorthwind Health Company, LLC55292235-bf8f-46d0-e063-6294a90a91a52026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.3e633cd0-5ee8-4a05-bcfc-0a80209bf27f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINUnit Dose Solutions, Inc.54ecc64b-f019-9fcb-e063-6294a90a00af2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.ddb3a54f-5224-4024-8804-b2a2f01d885e2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINCardinal Health 107, LLC41844c21-9e2a-4332-a8ff-9b71ae9032b02026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINA-S Medication Solutions03031adf-d36b-45ec-944e-dfce5a5de91a2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINCardinal Health 107, LLCd4f21e97-5e55-44c9-9b31-5f79ac2eb5122026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINMajor Pharmaceuticals999f3685-2eac-467e-bed2-1d0c36aaf0ed2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.fce0c123-29d7-42bf-8c8d-8be1772e2d992026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc83432-8fce-6d2a-e053-2a95a90ae73f2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN7eddc9ac-03ba-44c0-b630-ab683bf31e8e1
310431gabapentin 300 MG Oral CapsuleSCD7eddc9ac-03ba-44c0-b630-ab683bf31e8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5961-05009059610033 BLISTER PACK in 1 CARTON (50090-5961-0) > 1 CAPSULE in 1 BLISTER PACK33 blister pack2022-04-140000-00-00NoNoCurrent